Received May 14, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLUX | INFLUENZA (SEASONAL) (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | — | LA |
| VARZOS | ZOSTER (NO BRAND NAME) | UNKNOWN MANUFACTURER | 1 | C9X3R | LA |
impacted their ability to work; Fever; Outbreak of blisters/cold sores/now appear similar to cold sores; blisters appear on their face and nose; Pain; Itching; This non-serious case was reported by a consumer via call center representative and described the occurrence of fever in a 50-year-old female patient who received Herpes zoster (Shingles vaccine) (batch number C9X3R) for prophylaxis. Co-suspect products included Flu unspecified (Flu vaccine) for prophylaxis. Concurrent medical conditions included oral herpes (Patient reports having herpes since childhood, which would cause cold sores in their mouth.). On 15-NOV-2025, the patient received the 1st dose of Shingles vaccine (left deltoid) .5 ml and Flu vaccine (left deltoid). On 15-NOV-2025, less than a day after receiving Shingles vaccine and Flu vaccine, the patient experienced fever (Verbatim: Fever), cold sores (Verbatim: Outbreak of blisters/cold sores/now appear similar to cold sores), blister (Verbatim: blisters appear on their face and nose), pain (Verbatim: Pain) and pruritus (Verbatim: Itching). On an unknown date, the patient experienced impaired work ability (Verbatim: impacted their ability to work). The patient was treated with doxycycline hydrochloride (Doxycycline), minocycline hydrochloride (Minocycline), valaciclovir hydrochloride (Valtrex), hydrocortisone hydrogen succinate (Hydrocortisone), triamcinolone acetonide (Triamcinolone) and docosanol (Abreva). The outcome of the fever was resolving and the outcome of the cold sores, blister, pain and pruritus were not resolved and the outcome of the impaired work ability was not reported. It was unknown if the reporter considered the fever, cold sores, blister, pain, pruritus and impaired work ability to be related to Shingles vaccine and Flu vaccine. It was unknown if the company considered the fever, cold sores, blister, pain, pruritus and impaired work ability to be related to Shingles vaccine and Flu vaccine. Additional Information: GSK Receipt Date: 06-MAY-2026 Patient called GSK response center to report ongoing reactions following their first dose of Shingrix. Shingrix was administered 15-NOV-2025 along with an unknown flu shot, both in the left deltoid. Patient went to bed the night of injections with a fever of 103.5F. Fever subsided, but patient began to have blisters appear on their face and nose. These blisters eventually broke open and now appear similar to cold sores. Patient has had oral herpes since childhood. Outbreak of blisters/cold sores have not been managed. Patient reported blister on the side of their nose the size of a half dollar, as well as one on their face the size of a dime. Patient had been prescribed two rounds of antibiotics Doxycycline and Minocycline, neither of which have been effective. Patient also taking one gram of VALTREX weekly with no effect. Patient noted that the blisters/sores calm down at night, and flare up again a quarter of the way through the next day. Blisters were painful when touched and itchy, especially during flare ups. Patient uses hydrocortisone cream and bandages over blisters, as well as Triamcinolone steroid cream and Abreva, in addition to other unnamed creams. Patient was willing to provide pictures if prompted. Patient feels this situation had impacted their ability to work their customer-facing position due to severity of their condition which impacts their appearance. Patient noted that two other unidentified patients of the same provider reported similar adverse reactions after receiving two shots, including SHINGRIX. Patient notes they have never had a reaction to vaccines prior to SHINGRIX. Patient asserts they will not attempt the 2nd SHINGRIX dose. The batch number was not provided upon follow up with the reporter.
Oral herpes (Patient reports having herpes since childhood, which would cause cold sores in their mouth.)
Test Date: 20251115; Test Name: Body temperature; Result Unstructured Data: (Test Result:103.5,Unit:unknown,Normal Low:,Normal High:); Comments: 103.5F; Comments: LabComments: Body temperature 15-NOV-25: 103.5F